lantus versus levemir treat-to-target

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of hba1c \< 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (pg) ≤ 56 mg/dl (3.1 mmol/l) secondary objectives: * to compare between the 2 treatment groups, the percentage of patients who reach the target of hba1c \< 7% and \< 6.5% at the end of the treatment period * to compare the changes in hba1c and fasting plasma glucose (fpg) * to compare the evolution of blood glucose profiles * to compare the day to day fpg variability, the insulin doses * to determine in each treatment group the biochemical and patient-related determinants of failure to reach hba1c targets * to compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by pg ≤ 56 mg/dl (3.1 mmol/l) * to compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with pg ≤ 70 mg/dl \[3.9 mmol/l\]), of symptomatic day-time hypoglycemia (with pg ≤ 70 mg/dl and with pg ≤ 56 mg/dl), of severe hypoglycemia, of asymptomatic hypoglycemia with pg ≤ 56 mg/dl * to compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio * to assess the quality of life and treatment satisfaction


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 1 year * insulin naïve * treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day) * 7% ≤ hba1c ≤ 10.5 % * body mass index (bmi) \< 40 kg/m² * ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary exclusion criteria: * type 1 diabetes * current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week) * treatment with glucagon-like peptide (glp)-1 receptor agonists or with dipeptidyl peptidase (dpp)-iv inhibitors * active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry) * pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method) * breast-feeding * history of hypersensitivity to the study drugs or to drugs with a similar chemical structure * treatment with systemic corticosteroids in the 3 months prior to study entry * treatment with any investigational product in the 2 months prior to study entry * likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult * impaired hepatic function as shown by alamine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal range at study entry * impaired renal function as shown by serum creatinine ≥ 1.5 mg/dl (≥ 133 μmol/l) in men and ≥ 1.4 mg/dl (124 μmol/l) in women at study entry * history of drug or alcohol abuse in the last year the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.